ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?

Robin Zon, MD, FACP, FASCO

Members of the American Society of Clinical Oncology (ASCO) have articulated concerns regarding the current proliferation of clinical pathways in oncology that could affect patient access and care quality. In response, ASCO established an ad hoc Task Force, which issued a policy statement to guide the future development and implementation of these treatment management tools.

Need for More Data

At this juncture, the focus should be on learning, revising, and improving the process of pathway utilization through prospective research on current implemented pathways. Although some studies have shown that pathways can reduce costs while improving, or at least maintaining quality of cancer care, data are not complete.8 ASCO’s clinical pathways policy statement calls for additional research to understand the impact of pathways on care and outcomes.

ASCO Recommendations

ASCO envisions a collaborative effort for strengthening clinical pathways by involving all stakeholders, including physicians, patients, payers, clinical researchers, pathways developers, healthcare administrators, and policy makers—a specific recommendation articulated in its policy statement. Transparency, consistency, and the full promise of clinical pathways will not be fully realized until all concerns and perspectives are considered and thoughtfully addressed.

We believe that the ASCO policy statement will serve to engage all stakeholders in clinical pathways in oncology and facilitate a constructive dialogue for moving forward. The ASCO policy statement sets forth the following 9 recommendations that can provide the structure for this much-needed dialogue:

Pursue a collaborative, national approach to reduce the unsustainable administrative burdens associated with the unmanaged proliferation of oncology pathways. This would include eliminating preauthorization requirements if the patient meets the criteria for a selected pathway, and allowing physicians to select one, deemed pathway accepted by all payers.

Adopt a process for development of oncology pathways that is consistent and transparent to all stakeholders with public disclosure of methodologies for the pathway development and conflict of interest disclosures.

Ensure that pathways address the full spectrum of cancer care, from diagnostic evaluation through medical, surgical and radiation treatments, and include imaging, laboratory testing, survivorship and end-of-life care in order to maximize opportunities for value-based medical outcomes.

Update pathways continuously to reflect new scientific knowledge, as well as insights gained from clinical experience and patient outcomes, to promote the best possible evidence-based care. The emergence of big data and rapid learning systems further accentuate the need for rapid pathway refinements and more granular pathways to best serve the needs of distinct populations.

Recognize patient variability and autonomy, and allow for physicians to easily diverge from pathways when evidence and patient needs dictate. Appropriate variation considering varied patient comorbidities and therapeutic goals should be supported without significant administrative burdens.

Implement oncology pathways in ways that promote administrative efficiencies for both oncology providers and payers. In addition to removal of preauthorization when providers provide health services consistent with clinical pathways, the additional costs in complying with pathway adherence, which are not currently included in the codes for evaluation and management or care management, should be factored into payment for oncology services.

Promote education, research, and access to clinical trials in oncology clinical pathways. Furthermore, robust oncology pathways may help with collection of data outside of small trials and help advance understanding of therapy toxicities, patient comorbidities, and survival.

Develop robust criteria to support certification of oncology pathway programs; pathway programs should be required to qualify based on these criteria, and payers should accept all oncology pathway programs that achieve certification through such a process.

Support research to understand the impact of pathways on care and outcomes focusing on pathway development, dissemination and implementation, cancer care delivery, patient experiences, and impact on clinical outcomes and value.

The Future Vision for Pathways in Payment Reform

Oncology clinical pathways are likely here to stay, at least for the near future. Value-based pathways are considered by many an essential component of a comprehensive oncology payment reform initiative. This includes the ASCO model, which suggests payment adjustments based on quality, pathway adherence, and resource utilization, as well as alternative payment models such as the Oncology Medical Home. The future could also include the potential integration of rapid learning system data in optimizing the pathway evidence base, and therefore, improving the quality of patient care. Additionally, as pathways are used to measure outcomes, value-based pricing may also be realized, further promoting cost containment. The ASCO Value Framework, which assesses the relative value of cancer treatments by examining effectiveness, toxicity, and cost of regimens in a comparative manner, may also assist pathway development.9

The business model for incorporating pathways needs to be more fully examined and understood to assure sustainability of the care model for payers, providers, and patients. This includes mitigating administrative burden through oncology certification and acceptance of a deemed pathway by all payers.

Conclusion

ASCO believes there need to be uniform standards for the development and implementation of clinical pathways that are transparent to oncology stakeholders including physicians, patients, and payers.

Pathways should address the full spectrum of cancer care, and be updated in a timely manner to reflect new scientific knowledge, as well as insights gained from clinical experience and patient outcomes.

Clinical trial access should be considered an on-pathway option.

Pathways should recognize patient variability and autonomy, and off-pathway options when this is in the best interests of the patient.

Finally, pathways must be implemented in ways that promote administrative efficiencies rather than burdens for oncology patients, providers, and payers with strong consideration for certification and deeming of pathways.

Recognizing the critical importance of this issue for physicians, patients, and payers throughout the United States, ASCO’s Task Force on Clinical Pathways will continue its efforts to ensure that pathways are developed in such a way that ensures quality, consistency, transparency, and administrative efficiency to all stakeholders. Our recommendations will form the basis of this work, which will involve consulting with payers, vendors, providers, and others to develop a collaborative approach to ensure that clinical pathways promote—and don’t hinder—high-quality patient care. EBO

Acknowledgement: James N. Frame, MD, Charleston Area Medical Center, Charleston, West Virginia; Ray Page, DO, PhD, The Center for Cancer and Blood Disorders, Fort Worth, Texas; and members of the ASCO Task Force on Clinical Pathways, contributed to this commentary.